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NCT01460901 · ClinicalTrials.gov registry record · Phase 1
Study of Donor Derived, Multi-virus-specific, Cytotoxic T-Lymphocytes for Relapsed/Refractory Neuroblastoma
A Phase 1 study, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01460901: Completed Phase 1 study, sponsored by Children's Mercy Hospital Kansas City.
NCT01460901 is a Phase 1 study that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01460901, a Phase 1 study, has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory neuroblastoma expressing the mesenchymal tumor marker GD2. Three patients will be treated. The study will focus on the safety and efficacy of allogeneic, donor derived viral specific cytotoxic T-lymphocytes, retrovirally transduced to express a chimeric antigen receptor specific for disialoganglioside, GD2, expressed on neuroblastoma.
Primary Outcome
Immediate: Patients were monitored following infusion to assess for toxicity related to infusion. Potential toxicities related to cellular therapy infusions, such as allergic reaction to the cellular product or cryopreservation media, hemolytic reactions, volume overload, and hemodynamic instability, were monitored. Short Term: Patients were monitored for 8 weeks for short term toxicity related to infusion. Such adverse reactions monitored were acute graft versus host disease and cytokine relea
Interventions
- BIOLOGICAL GD2 CAR modified Tri-virus specific cytotoxic t-cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT01460901 record still lists
NCT01460901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which GD2 CAR modified Tri-virus specific cytotoxic t-cells is the first listed.
NCT01460901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01460901 about?
NCT01460901 is a clinical study titled "Study of Donor Derived, Multi-virus-specific, Cytotoxic T-Lymphocytes for Relapsed/Refractory Neuroblastoma". This is a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory neuroblastoma expressing the mesenchymal tumor marker GD2. Three patients will be treated. The study will focus on the...
What is the current status of trial NCT01460901?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2012-10. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01460901?
The interventions under investigation include: GD2 CAR modified Tri-virus specific cytotoxic t-cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01460901?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01460901's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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